MDCG 2020-13: Clinical evaluation assessment report template (CEAR), explained

Who this applies to

The template is formally for notified bodies assessing a manufacturer's clinical evaluation under the MDR. It standardises how the assessor records the work performed and the conclusions reached during an initial conformity assessment, surveillance, recertification, or an assessment triggered by a change.

Manufacturers should read it too. It reveals the questions sitting on the other side of the audit table and is therefore a strong internal checklist before submitting technical documentation. Do not, however, fill it out and present it as your own compliance document: the CEAR records the notified body's independent assessment.

What the assessor starts with

The opening sections establish the assessment context: manufacturer and device, Basic UDI-DI where available, class and classification rule, conformity-assessment route, novelty, implantable status, intended purpose, variants, accessories, certificates, and the documents and versions reviewed.

This administrative detail is substantive. If the CER describes a different population, variant, software version, indication, or intended user from the risk file, IFU, SSCP, or certificate scope, the assessor cannot reach a clean conclusion. A good submission has one controlled device definition propagated everywhere.

The notified body also records the assessor's competence, possible conflicts, and the depth of assessment. That mirrors what manufacturers need from their clinical evaluators: documented education, training, experience, product knowledge, methodology knowledge, independence, and a justified team where one person does not cover every discipline.

How the clinical evaluation is assessed

The CEAR follows the clinical-evaluation process rather than merely checking for a signed final report. It prompts the assessor to examine:

The template asks the notified body to identify both the evidence reviewed and its own assessment. That is why a long CER is not necessarily an assessable CER. The evidence chain must let an independent reviewer move from a claim or GSPR to the data, appraisal, analysis, uncertainty, and conclusion.

Consistency across the technical documentation

Clinical evaluation does not stand alone. The assessor checks its relationship with risk management, PMS, PMCF, usability, verification and validation, biological evaluation, labelling, instructions for use, and the SSCP where applicable.

Typical inconsistencies include a risk file that calls an outcome unacceptable while the CER calls it expected, claims in the IFU that have no defined clinical benefit or supporting evidence, PMCF activities that do not address the CER's gaps, and complaint or vigilance information omitted from the clinical-data analysis. Fixing the wording in the CER alone does not fix those system failures.

How conclusions and findings are recorded

The notified body records whether the clinical evidence is sufficient for conformity, whether the benefit-risk determination is acceptable, and whether PMCF and update arrangements are adequate. It documents deficiencies, follow-up actions, and restrictions or conditions that affect certification.

For class III and certain class IIb devices, the template also helps capture aspects relevant to the clinical evaluation consultation procedure. For devices using an exemption or an alternative evidence route, the assessor needs a clear legal and scientific rationale, not just a reference to an MDR article.

Treat each “not applicable” decision as a conclusion requiring justification. If there is no clinical investigation, no PMCF study, no equivalence, or no particular data source, show why the remaining route and evidence are adequate for this device.

Use the template as a submission-readiness review

An internal reviewer who was not the CER author should walk the CEAR prompts and record where the answer is located. This simulates the notified body's task and exposes circular references, missing versions, evidence that cannot be found, and conclusions that depend on undocumented expert knowledge.

Do not copy the CEAR headings blindly into the CER. Your clinical evaluation should follow its approved plan and fit the device. Use the template to test coverage, traceability, consistency, and the strength of reasoning.

What this means for you, practically

1. Freeze the device scope before review. Reconcile intended purpose, variants, class, claims, populations, users, versions, and identifiers across the CER and the rest of the technical documentation.
2. Create a claim-to-evidence index. For every clinical benefit, performance claim, risk conclusion, and relevant GSPR, point to the data, appraisal, analysis, and residual uncertainty.
3. Run an independent mock CEAR. Ask a qualified reviewer who did not write the CER to locate and challenge every answer the notified body will need.
4. Resolve cross-document conflicts. Track each inconsistency to the source document and owner rather than patching a sentence in the CER.
5. Make gaps actionable. Translate every accepted uncertainty into a PMCF or PMS activity with a method, owner, timeline, acceptance criterion, and defined downstream update.

Read the official MDCG 2020-13 CEAR template.